Augmenting Excipient Functionality - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Augmenting Excipient Functionality


Pharmaceutical Technology
Volume 34, Issue 7, pp. 48-52

Expansion activity

Excipient manufacturers also are investing through tactical acquisitions, capacity, enhancements, and product enhancements.

Manufacturing and service expansions . EMD, part of Merck KGaA (Darmstadt, Germany), started construction earlier this year on a new production plant in Darmstadt for the production of inorganic salts. The company is investing approximately EUR 30 million ($37 million) in planning, developing, and constructing the plant, which will produce excipients, active ingredients, products for biopharmaceutical production, food additives, and laboratory reagents. The expansion will increase the plant's current capacity by approximately 50%. The plant is scheduled to begin production in mid-2011.

In May 2010, Lubrizol Advanced Materials, part of Lubrizol (Cleveland, OH), announced an investment of approximately $40 million at its manufacturing facility in Calvert City, Kentucky. The facility specializes in the production of the company's Carbopol polymers, which are used as pharmaceutical excipients and in personal and home care products.

Roquette (Geneva, IL) broke ground in May 2010 for an innovation center in Geneva, Illinois. The center will serve the pharmaceutical, nutritional, nutraceutical, and biochemical markets.

In May 2010, ISP expanded its laboratory in São Paulo, Brazil, to add equipment for developing pharmaceutical pellets and evaluating excipient and coatings in pharmaceutical pellets prepared by extrusion spheronization. A laboratory-scale extruder and multibowl spheronizer will be used to develop modified-release forms using extrusion spheronization.

Earlier this year, Sheffield Bio-Science (Beloit, WI) and the dairy product company Foremost Forms USA (Baraboo, WI) established dual manufacturing locations for lactose excipients. In addition to a current production facility in Norwich, New York, the two companies are coinvesting in a second anhydrous lactose manufacturing facility in Rothschild, Wisconsin. This additional capability is expected to be completed in December 2010. The two companies also are in the process of validating a second manufacturing location in Plover, Wisconsin, which will be capable of manufacturing various spray-dried lactose excipients.

Archer Daniels Midland Company (ADM, Decatur, IL) invested in a propylene glycol plant in Decatur, Illinois, which is capable of producing industrial grade and USP grade propylene glycol, which may be used as a pharmaceutical excipient. The plant manufactures a grade of USP-grade propylene glycol from renewable sources, derived from soybeans or rapeseeds, which are a source for glycerin production. The glycerin can be reacted through a hydrogenolysis process into propylene glycol, which is further distilled into the appropriate grade.

Acquisitions and alliances . In April 2010, Colorcon (Harleysville, PA) acquired the pharmaceutical excipient company, NP Pharma (Bazainville, France), a subsidiary of Ethypharm (Saint-Cloud, France). The acquisition of NP Pharma gives Colorcon additional capabilities in sugar spheres. Colorcon now has two production facilities for sugar spheres, which include microcrystalline cellulose pellets and neutral pellets for direct compression.

Meggle (Wasserburg, Germany) formed a partnership last November with the food ingredient company Davisco Foods (Eden Prairie, MN) for the production of pharmaceutical lactose in the United States. Davisco is expanding its existing lactose production at its facility in Le Sueur, Minnesota, under that partnership.

DMV-Fonterra Excipients (Princeton, NJ), a 50–50 joint venture for pharmaceutical excipients between the food company Royal FrieslandCampina (Amersfoort, The Netherlands), and Fonterra, a New Zealand-based dairy cooperative, agreed to buy the pharmaceutical lactose activities of FrieslandCampina Domo, effective March 2010. The transaction entails the formulas, marketing activities, sales, distribution channels, and use of the Domo name for pharmaceutical excipients.

Other product and technology offerings . Last November, BASF (Ludwigshafen, Germany), launched an automated formulated color-coating system for immediate-release film coatings. The system is designed to increase productivity and reduce development time encountered in manual color systems.

BENEO-Palatinit (Mannheim, Germany) introduced last October the sugar-free excipient galenIQ 981, a pharmaceutical grade of isomalt. The product is a replacement for sugar in coatings of solid pharmaceutical dosage forms such as tablets, pellets, and compressed chewing gums.

The product addresses the challenge of replacing sucrose, a traditional coating agent, with an alternative that can retain the protective, aesthetic and taste advantages of a sugar coating. One alternative, film-coating, eliminates the disadvantages of sucrose but also the advantages of a sugar coating, according to the company.

Dow Polyglycols and Surfactants, a business unit of The Dow Chemical Company (Midland, MI) introduced last October a new variety of Carbowax and Sentry polyethylene glycol that comes in flakes, which provides an alternative to granular products. The addition of the new grade is tied to a capacity expansion announced by Dow in 2007.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,
.

References

1. P. Van Arnum, Pharm. Technol. 32 (4), 56–62 (2008).

2. P Van Arnum, Pharm. Technol. 32 (7), 96–101 (2008).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here